Summary of Regulatory Trends and Expectations for Submission Review and Field Inspections

Revised Aseptic Processing Points to consider and updates to EU Annex

Review of Updated USP Chapter 1116

Mitigating Risks associated with Aseptic Parenteral Filling and PAI’s

Regulatory update and inspection trends from Brazil

About the Speakers

Sam Elrashidy was the Associate Director at Bayer Healthcare, Emeryville, California; He was overseeing all activities related to Microbiology, Environmental Monitoring, DNA sequencing & Identification and Sub-Visible particulate testing within the Quality Control Department. Sam has over 25 years of experience in the Pharmaceutical and Industrial Microbiology areas and his experience covers all areas of Microbiological testing for Pharmaceuticals (Small and Large Molecules), Medical devices, Vaccines and Cosmetics.
Sam holds a M.Sc. degree in Molecular Biology and Genetics and attended the graduate school at Rutgers University, NJ for a Ph.D. in Microbial genetics.
Sam has been an active member of the PDA, he served as chair, committee member and moderator for the PDA Annual Global Pharmaceutical Microbiology Conference for the past seven years. He also, serving as a committee member and moderator for the PDA Annual Aseptic Processing-Sterilization Conference and he is an active member of a PDA task force responsible for writing a PDA Technical Report on Microbiological Data Deviations.Sam was awarded the PDA Distinguished service award in 2015.

Melissa Morandi is currently the Vice President of Global Quality for Aegerion Pharmaceuticals, and international company focused on the development and commercialization of orphan drugs. Previously, she was Vice President of Quality at Acceleron Pharma, a biotech company manufacturing fusion proteins for clinical research in unmet medical needs. She was also Vice President of Quality at Anesiva Inc., with leadership responsibilities for the design control, validation, regulatory approval, and launch of ZingoTM, a novel needle free intradermal drug injection system.
Prior to joining Anesiva, Ms. Morandi held director positions in Quality and Compliance at Biogen Idec Inc. and she spent nine years managing several Quality departments at Genentech, Inc. including Lot Release, Product Quality and Complaints, Supplier Quality, Contract Manufacturing, Collaborations, and Compliance Auditing. Prior to that, she worked at Amgen Inc. in Quality Assurance supporting product launches, new facility preparations for GMP approval, compliance auditing and lot release for Epogen® and Neupogen®. She holds a B.A. degree from the University of California at Santa Barbara and a M.S. degree in Immunology from California State University at Northridge. She is Regulatory Affairs Certified (R.A.C.).
Ms. Morandi has been a board member for the West Coast Chapter of the Parenteral Drug Association since 2009.

We all have seen Ebola in the news. To date, Ebola in the U.S. has been isolated to some health care workers who had gotten infected while in Africa treating Ebola patients. In order to control the spread of the virus, hospitals have begun to take extreme measures. One issue concerning health care workers is the efficacy of the disinfectants being used against the virus. Currently, there is no disinfectant specifically approved for the treatment of Ebola.

The EPA and other regulatory agencies require that virucidal claims for disinfectant agents can only be made for the specific viruses tested. Testing Ebola is very dangerous and it needs a biosafety level 4 (BSL4) facility to perform the studies.

The highly infectious Ebola virus causes hemorrhagic fever in humans, leading to damage of the inner organs and hemorrhages. It has a human mortality rate of 50% to 90%. The Ebola virus is transmitted through direct contact with body fluids such as saliva, blood, or feces from patients infected with the Ebola virus disease (EVD) or dead EVD patients. The virus can remain infectious on surfaces between five days and three weeks. Studies show that the virus has a potential of being transmitted by air by small droplets of fluid from sneezing or mucus.

According to the EPA, there are no EPA-registered products with specific label claims against the Ebola virus. Enveloped viruses such as Ebola are susceptible to a broad range of hospital disinfectants used to disinfect hard, non-porous surfaces. In contrast, non-enveloped viruses are more resistant to disinfectants. As a precaution, the selection of a disinfectant product with a higher potency than what is normally required for an enveloped virus is being recommended by the CDC at this time. EPA-registered hospital disinfectants with labeled claims for hospital disinfection (or the equivalent microbial pathogen claims) and claims against non-enveloped viruses (e.g., norovirus, rotavirus, enterovirus, Hepatitis A&E, adenovirus, poliovirus) are broadly antiviral and capable of inactivating both enveloped and non-enveloped viruses, and are used to disinfect environmental surfaces in rooms of patients with infectious diseases.

When testing a disinfectant for virucidal efficacy against Ebola, a decision must be made concerning which virus to use since testing with Ebola is not feasible in a normal lab setting. At this time, the EPA is not allowing labeled claims related to antimicrobial product efficacy specifically against the Ebola virus since a scientifically available testing procedure with a surrogate has not been developed. As a precaution, the CDC recommends disinfectants that have been tested against non-enveloped viruses for use to disinfect Ebola contaminated areas or items. Disinfectants with a General Virucide Claim are effective against enveloped and non-enveloped viruses.

MQA can help you design a study for efficacy evaluation of your disinfectant for bacteria, fungi and viruses.

Please contact Mimi Leong at mleong@microqa.com for more information on services in San Francisco Bay Area, Oakland and Berkeley

Contract Research Organizations (CRO’s) Are Changing the Biotech Start-Up Model

The use of contract research organizations (CRO) by small specialized biotech companies in the San Francisco Bay Area has increased over the last few years due to the expertise, infrastructure, and staffing a CRO can offer. The already established CRO makes it possible for young biotech companies and drug development companies to move quickly and at a cost effective pace. Now, CRO’s play a critical role in all aspects of the R&D pipeline. [Read more…]

What does it mean to be ISO/IEC 17025:2005 Accredited vs. ISO 9001 Certified?

“A laboratory’s fulfillment of the requirements of ISO/IEC 17025:2005 means the laboratory meets both the technical competence requirements and management system requirements that are necessary for it to consistently deliver technically valid test results and calibrations. The management system requirements in ISO/IEC 17025:2005 (Section 4) are written in language relevant to laboratory operations and meet the principles of ISO 9001:2008 Quality Management Systems – Requirements and are aligned with its pertinent requirements.”

Microbiology & Quality Associates, Inc. (MQA) was originally granted ISO/IEC 17025:2005 accredited status on November 8, 2012 by the American Association for Laboratory Accreditation (A2LA).

MQA hosted a renewal assessment in December 2014 and was approved for continued accreditation on December 24, 2014 by A2LA. MQA’s Certificate Number is 3383.01 and is valid through December 31, 2016. Our scope of accreditation includes 16 different biological assays and 3 chemical test procedures. In addition, two of our biological tests meet the requirements of A2LA R104 – General Requirements: Accreditation of Field Testing and Field Calibration Laboratories.

MQA applies the same ISO/IEC 17025:2005 accredited Quality System to all laboratory and calibration testing services performed at MQA even though the assays are not specifically listed on the Scope of Accreditation. MQA is also registered as a Drug Establishment Firm with the FDA (FEI 3006616583) with an expiration date of December 31, 2015.

Certifications

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